Senior System Engineer

Coalesce Management Consulting; Hillerød Kommune; On-site; DKK 700,000 - 900,000; Full time

Job summary

Coalesce Management Consultancy (CMC) seeks a Senior Systems Engineer to work on a Copenhagen, Denmark project. The candidate should have a mechanical engineering background with experience in pen injectors and drug delivery systems, supporting early stage development projects.

The role involves applying systems engineering principles, leading requirements definition, traceability, and risk assessment across multidisciplinary teams and external consultants. On-site requirement emphasized.

Qualifications

• Proven experience in systems engineering within the medical device sector.
• Mechanical background with experience on pen injectors or drug delivery systems.
• Experience with ISO 11608 (needle-based injection systems for medical use).
• Strong background in requirements management and risk assessment.

Responsibilities

• Lead systems engineering activities including requirements definition and traceability.
• Work with mechanical and systems engineering teams on pen injector development.
• Conduct risk analysis and hazard identification.
• Translate user needs into technical specifications.
• Support design and development activities from a systems and mechanical perspective.

Skills

Systems engineering

Medical devices

Pen injectors

Requirements management

Risk assessment

Independent consulting

Education

Mechanical or Systems Engineering degree

Tools

Requirements management software

Job description

Coalesce Management Consultancy (CMC) have a consulting assignment available for a Senior Systems Engineer, to work on a project we have in Copenhagen, Denmark.

CMC provide expert engineering solutions on an international capacity for Advanced Engineering projects. Established in 2016, we set out our mission to be the best service-driven consulting business in global STEM markets, and after rapid growth in just a few years, we're already delivering true expertise to major technology brands and leading companies around the world.

We are looking to support one of our project teams with a Senior Systems Engineer, for a project we are supporting a client with.

Overview

We are looking for a systems engineer with a mechanical engineering background and experience with pen injectors and drug delivery systems to support early stage development projects. The role involves applying systems engineering principles to new product concepts for combination products.

Responsibilities

• Lead systems engineering activities including requirements definition and traceability.
• Work with mechanical and systems engineering teams on pen injector development.
• Conduct risk analysis and hazard identification.
• Translate user needs into technical specifications.
• Support design and development activities from a systems and mechanical perspective.

Requirements

• Proven experience in systems engineering within the medical device sector.
• Mechanical background with experience on pen injectors or drug delivery systems.
• Experience with ISO 11608 (needle-based injection systems for medical use).
• Strong background in requirements management and risk assessment.

You would be able to operate as an independent consultant or employed consultant for this assignment, which I can support with. You will also be required to go on-site.

No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.